Health leaders and politicians entire job is to build and maintain trust. Mistakes like this only reinforce vaccine hesitancy. Those that are hesitant know that the science is settled - until it isn't. The only method to account for unknown unknowns is time.
It would have been entirely possible for Fauci et. al to say "The vaccine data appears to show 95%+ efficacy, but we will be waiting to lift lockdown mandates be sure". That kind of messaging shows both a respect for science and a commitment to everyone's health. However, it was an unpopular political decision, so mandates were lifted.
This isn't the first time they've changed their course after making a decision prematurely. To the vaccine hesitant, why is this FDA approval any different? There's massive political pressure to approve these vaccines.
pausing causes vaccine hesitance, but finding out that the authorities knew about potential risks like this and didn't pause the rollout to assess those risks also causes vaccine hesitance, and is also poor politics.
they did the safe thing, regardless of the politics. if you're skeptical about vaccines you should be reassured by that. and if a person is skeptical about vaccines but somehow isn't reassured by the authorities taking responsible safety precautions, they're probably not coming from a place of reason and there's not much point worrying what they think.
I think it is clear the regulatory framework wasn't ideal.
The last stage of the trial (which took three months) was not about if they were safe - but simply if they worked. Meaning, they were cleared to have minimal side effects, just unclear if it worked.
If you had approved people to choose to take the vaccine in August we could have had 50M people with shots already.
A lot of people have my skepticism that the main reason that the FDA didn't want to do that since it might be a bit of a media heartache for them, but so what. Even if you thought it would only work 20% of the time that 20% of the time it saves 100,000+ lives.
It’s not a pivot for me, particularly since I got the vaccine, but I think there are legitimate reasons to be hesitant and removing one reason doesn’t invalidate other reasons people may bring up. The big one in my mind is how do Pfizer, BioNTech, or the FDA validate safety of the vaccine over the long term? For instance what if it turns out that something approved today turns out to be carcinogenic twenty years from now? This is one reason I feel mandating vaccines or coercing people using other means (like creating great inconveniences) is not okay.
It also does seem like the approval process may be influenced by political pressure to remove barriers to hesitancy or to support vaccine mandates. My understanding is that the approval timeline here is faster than any previous one. Did the FDA really review the over 300,000 pages submitted for this approval and scrutinize it to the extent necessary? Maybe. But from the outside it seems suspiciously quick based on relative terms.
What's shocking in all of this is how they handled two conflicting potency results.
A rational person would see two conflicting measurements and then stop to figure out why they are different, and then re-run measurements to verify the results until they know why they're different and which one is wrong.
These guys just said "We'll just trust the results from OUR measurements over THEIR measurements", which is the height of arrogance and stupidity. These kinds of mistakes can have dire consequences because you're no longer testing based on how the vaccine will be used in the real world once approved. To say "Well, it worked out in the end so no harm" is also incredibly arrogant and foolish.
Just like I trust the regulators for vaccine approval, I trust them in the decision of stopping the administration of a vaccine to further investigate the problem. This goes together.
It's not a political decision no matter how many people try to spin this. This is the outcome of doctors reporting an anomaly to a regulator. The system is working, and this should give you reassurance, not doubt about the consequences of stopping a vaccine.
I'm pretty sure they know the consequences of this setback, so for them to stop it it's because something is not right.
its really interesting/disturbing that people put so much blind faith in the organizations pushing these vaccines. so many people are acting unscientifically in the "pursuit of science". science is not something where you blindly trust what the corporations and authority figures tell you.
the safety trials had no control group, the approval was based on 4 months of data, the situation that we are in now seems to suggest they dont really work very well, there certainly is no long term data about what happens when you keep reinjecting boosters over and over, lipid nanoparticles themselves are a novel technology that is not very well understood, most people are at low risk and have no need for it, the list goes on
This will be overcome. It was about trusting the scientists instead of the White House. I'm fine with it now. But didn't they pressure that CDC director to approve it that day or get fired? They were probably going to approve already. But what if they weren't far enough along and some of this nonsense would've played out like that? It'd have been very harmful for the trust in the vaccine.
That's just it: we are not adequately cautious. Who knows what the long-term side effects of the vaccines will be?
The fact that those concerns are hand-waved away makes me more concerned. I mean, I don't trust Big Pharma, but at the very least, the FDA stood in their way. This time, the FDA gave them a pass called "Emergency Use Authorization," and that worries me.
It's harder to dismiss when you also consider the first vaccine approvals kept getting delayed until they were released immediately after the election.
Pausing like that causes, not prevents, vaccine skepticism. In an era of declining public trust of institutions (across both political aisles, even if unequally), I argue this pause was poor politics. Science doesn't enter much into it, unfortunately.
Because the vaccine was released almost a year prior and it didn't have approval but governments and individuals wanted it so bad.
If that's what validates your reality, then call your senators about removing the exemption from liability after the FDA approval. Advocate for that.
One thing I've been having fun with is imagining how people will move the goalpost after the FDA decision. I wonder how many people upon approval will say "ah the FDA is controlled by big pharma and other shadow masters!" If not approved "ha I knew it!" I wonder how many others will read the clinical trial studies the the FDA is evaluating (which are already available now) and reach a conclusion that agrees with the FDA.
Well, they spent a year telling us that no vaccine had ever been developed in less than 5 years and that Trump’s promises of a vaccine in less than a year were impossible. Then, within a month of the election, they said it had been developed and was perfectly safe. There’s some call for skepticism here.
If the FDA prematurely approved a vaccine which was later found to have serious side effects that would destroy public confidence in vaccines for generations. Be patient.
I find this to be unreasonable.
How would they have known in March which vaccines proved to be effective?
Even if they’d guessed right, how many people would have taken an untested vaccine?
And what if a lot of people had, and then side effects show up. That would probably cost more lives over the next decade by public distrust of the drug approval process.
To a point that's understandable, based just on trials it's reasonable to be skeptical of the results. However once the vaccines have been in mass distribution and there is copious evidence of their efficacy and the extreme rarity of adverse affects, I don't think it's reasonable anymore.
The mandates only came in once enough of the population had been inoculated to make a requirement possible. At that point the initial trials are a footnote compared to the results from mass vaccinations. IMHO it's just not reasonable for that objection to carry any weight. There may be other reasons, of course.
Yes, the fact that they are being this cautious is a good thing for public trust. We have other vaccines as well. I rather have this level of transparency then blindly tell people to get JJ and we will figure out edge cases later.
Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor.
The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence.
Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
It's not hard to imagine that rushed trials, rushed production and pressured approvals might not lead to the best process.
Next to that: Over the last 50-60 years approved medicines with the backing of more extensive clinical trials have been withdrawn. So the whole process in itself isn't flawless.
I'm not saying the vaccines are unsafe or all the processes are wrong, but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair.
It would have been entirely possible for Fauci et. al to say "The vaccine data appears to show 95%+ efficacy, but we will be waiting to lift lockdown mandates be sure". That kind of messaging shows both a respect for science and a commitment to everyone's health. However, it was an unpopular political decision, so mandates were lifted.
This isn't the first time they've changed their course after making a decision prematurely. To the vaccine hesitant, why is this FDA approval any different? There's massive political pressure to approve these vaccines.
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